Johnson & Johnson Said to Agree to $4 Billion Settlement Over Hip Implants - NYTimes.com

This settlement is only possible because J&J took advantage of the substantial equivalence loophole that enabled them to avoid full FDA pre-market review.  If they had not been able to claim that their new metal-metal design was not substantially equivalent to pre-1976 devices they would have had to run extensive clinical rials, etc.  That would have gained them immunity thanks to the Supreme Court pre-emption 8-1 ruling in 2008 Riegel v. Medtronic, from which only Ruth Ginsburg dissented. That deplorable ruling immunized companies like Medtronic from liability for the thousands of people in whom defective pacemaker wires were implanted. - GWC
Johnson & Johnson Said to Agree to $4 Billion Settlement Over Hip Implants - NYTimes.com:
By BARRY MEIER
Published: November 12, 2013

Johnson & Johnson has tentatively agreed to a settlement that could reach up to $4 billion to resolve thousands of lawsuits filed by patients injured by a flawed all-metal replacement hip, said two lawyers briefed on the plan.

The tentative plan, which must win court approval, represents one of the largest payouts for product liability claims involving a medical device.

A spokeswoman for the company’s DePuy Orthopaedics unit declined to comment on the possibility of a settlement. An announcement about the plan is expected in the coming days, the lawyers said.

The agreement will include those patients who have already been forced to have the device, known as the Articular Surface Replacement, or A.S.R., removed and replaced with another artificial hip, said the lawyers who spoke about the agreement only on the condition of anonymity.

Under the deal, each patient would receive about $350,000 on average in compensation, though that figure will vary depending on factors like a patient’s age and medical condition.

The precise value of the settlement is unclear because lawyers for patients are still trying to estimate how many of the 12,000 related lawsuits involve patients who had a replacement. Lawyers believe that number may be 7,000 to 8,000 cases.


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